07.27.26 -- Building CGT Manufacturing Capacity For The Next Commercial Era

Discover how a proprietary transposase technology works and why it can be beneficial for the development process for the expression of biologics.

Integrating yeast extracts can boost E. coli protein yields by half and improve desired attributes fourfold, providing a highly reliable, animal-free nutrient alternative.

In vivo CAR-T scales patient access and cuts timelines but turns biological hurdles into complex manufacturing demands. Precise assays and tight raw material controls are vital for regulatory success.

Setting up a CGT product for regulatory viability and commercial success means investing to empower process design, plus on-time planning of PPQ and CPV activities.

Explore challenges and solutions in developing novel AAV capsids, focusing on manufacturing complexity, analytical testing, and regulatory considerations for advancing gene therapy effectiveness.

Learn how this framework can accelerate your viral vector, CAR-T, and iPSC programs, reduce risk, and streamline your path from development to commercial manufacturing.

Securing high-quality cell collection for advanced therapies depends on access to a large, diverse donor pool as well as robust donor screening and efficient collection practices.